search
Back to results

Oncology Dashboard for the Improvement of Operational Efficiency and Patients Outcomes in Patients With Sarcoma

Primary Purpose

Sarcoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Informational Intervention
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with sarcoma on active chemotherapy/targeted therapy
  • Patients must have stable to mildly progressive disease or better on baseline assessment

    • Baseline measurement and follow-up measurement have to be performed on the same treatment for consistency. If patients with progressive disease are included into the study at baseline, follow-up measurement will be on a different treatment. Invariable, initiation of a new treatment, in the setting of progressive disease, lengthens oncology workflow which would affect the post measurement
  • Patients must have been on the same treatment for at least 6 weeks
  • Patients must have at least 3 prior imaging studies of the same body part/tracked lesion/area of interest separated by 6 weeks or more between studies
  • Patients should be continuing same therapy for the next 6-8 weeks
  • Patients must have plan for follow-up with imaging studies at MD Anderson Cancer Center (MDACC) while on therapy
  • Patients who are receiving therapy outside of MDACC but having their follow-up imaging at MDACC are eligible
  • >= 18 years of age

Exclusion Criteria:

  • Expected survival of less than 8 weeks
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 4

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I (oncology dashboard)

Group II (standard of care)

Arm Description

Radiologist records information from patient's recent scan into oncology dashboard. Patients view images of how disease may have changed over time on oncology dashboard.

Patients receive standard of care.

Outcomes

Primary Outcome Measures

Time to complete medical oncology review (oncology workflow)

Secondary Outcome Measures

Full Information

First Posted
January 18, 2022
Last Updated
August 28, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT05216029
Brief Title
Oncology Dashboard for the Improvement of Operational Efficiency and Patients Outcomes in Patients With Sarcoma
Official Title
Study of Efficacy of Oncology Dashboard in Improving Operational Efficiency and Patient Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical trial investigates whether measuring and presenting information about a patient's cancer treatment to them, their doctor, and their radiologist using a tool called an "oncology dashboard" may help patients understand the disease better and help the patient's medical team manage their care more efficiently. The oncology dashboard tool may help patients understand the disease better and may help improve the efficiency of their medical care.
Detailed Description
PRIMARY OBJECTIVE: I. To compare the changes in oncology workflow times from baseline to follow up visits between intervention (follow-up visit with oncology dashboard tool) and control (follow-up visit without oncology dashboard tool) groups. SECONDARY OBJECTIVES: I. To compare the changes in radiology workflow times from baseline to follow up visits between intervention (follow-up visit with oncology dashboard tool) and control (follow-up visit without oncology dashboard tool) groups. II. Assess and compare the proportion of patients who correctly indicate the changes in tumor size while on therapy at the baseline and at the follow-up visit (with the oncology dashboard tool). IIa. Compare the change in proportion of patients who correctly indicate the changes in tumor size while on therapy from baseline to follow-up visit between intervention and control groups. III. Assess the patient's satisfaction with physician communication during the clinic visit and with the current treatment plan at each visit for each group. IV. Assess changes in the radiology report quality with the following measures (all changes will be compared between intervention and control groups): IVa. Whether or not the current study was compared to the imaging study that was performed at the start of current therapy. IVb. The number of time points reviewed by the radiologist. IVc. The time interval between the earliest study reviewed and the current study. IVd. Percentage of target lesions measured and listed in the radiology report. V. In patients who have stable disease or mildly progressive disease at the time of the baseline assessment, assess the impact of patient understand on the decision to continue and discontinue therapy. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Radiologist records information from patient's recent scan into oncology dashboard. Patients view images of how disease may have changed over time on oncology dashboard. GROUP II: Patients receive standard of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (oncology dashboard)
Arm Type
Experimental
Arm Description
Radiologist records information from patient's recent scan into oncology dashboard. Patients view images of how disease may have changed over time on oncology dashboard.
Arm Title
Group II (standard of care)
Arm Type
Experimental
Arm Description
Patients receive standard of care.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard of care
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
View oncology dashboard
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Time to complete medical oncology review (oncology workflow)
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with sarcoma on active chemotherapy/targeted therapy Patients must have stable to mildly progressive disease or better on baseline assessment Baseline measurement and follow-up measurement have to be performed on the same treatment for consistency. If patients with progressive disease are included into the study at baseline, follow-up measurement will be on a different treatment. Invariable, initiation of a new treatment, in the setting of progressive disease, lengthens oncology workflow which would affect the post measurement Patients must have been on the same treatment for at least 6 weeks Patients must have at least 3 prior imaging studies of the same body part/tracked lesion/area of interest separated by 6 weeks or more between studies Patients should be continuing same therapy for the next 6-8 weeks Patients must have plan for follow-up with imaging studies at MD Anderson Cancer Center (MDACC) while on therapy Patients who are receiving therapy outside of MDACC but having their follow-up imaging at MDACC are eligible >= 18 years of age Exclusion Criteria: Expected survival of less than 8 weeks Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 4 Non- English-speaking patients and patients with cognitive impairment who cannot complete the questionnaire
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinod Ravi
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

Oncology Dashboard for the Improvement of Operational Efficiency and Patients Outcomes in Patients With Sarcoma

We'll reach out to this number within 24 hrs